Automation of Transfusion Service 10/22/2007

2:00PM – 5:30PM

Event Outline

Event Title: 5323-TC Automation of Transfusion Service Event Director: Suzanne Butch Event Date: Monday, October 22, 2007, 2:00 PM to 5:30 PM Presenters: Theresa Downs

Pia Bruce Nancy Nikolis Leana Serrano-Rahman Ann Kirsch

Time Speaker Presentation

2:00 PM to 2:30 PM Nancy Nikolis Issues In Selecting Automation for the Transfusion Service

2:30 PM to 3:00 PM Leana Serrano-Rahman Validation and Correlation of Blood Bank Analyzers

3:00 PM to 3:30 PM Theresa Downs Interfacing Your Automating Instrument

4:00 PM to 4:30 PM Ann Kirsch Training Automation in the Transfusion Service

4:30 PM to 5:00 PM Pia Bruce international regulations and need for a data interchange standard

EVENT FACULTY LIST

Event Title: 5323-TC Automation of Transfusion ServiceEvent Date: Monday, October 22, 2007 Event Time: 2:00 PM to 5:30 PM

Director Suzanne Butch MA, MT(ASCP)SBB, CQA(ASQ) Blood Bnak UH 2F225 SPC 5054 1500 E. Medical Center Drive Ann Arbor, MI, 48109-5054, USA (734) 936-6861 butchs@umich.edu

Disclosures: Yes

Speaker Pia Bruce M.Sc., MBA +358 9 5801564 Pia.Bruce@veripalvelu.fi

Disclosures: No

Speaker Theresa Downs MT(ASCP)SBB UH2F225/Box 0054 1500 East Medical Center Drive Ann Arbor, Michigan, 48109, USA 734-936-6862 tdowns@umich.edu

Disclosures: No

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International Regulations and Need for a Data Interchange Standard

22 October 2007

P. Bruce, M.Sc., MBADevelopment Director, Production Process

Finnish Red Cross Blood Service

AABB 2007

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Agenda

• Finnish Red Cross Blood Service• Laboratory Information Management

System (LIMS) in Blood Service and examples of our interfaces

• Regulations• Guidelines• Good Automated Manufacturing

Practise (GAMP)• Data interchange challenges faced• Standardization and data interchange• Need for a data interchange standard

in transfusion medicine activities• Conclusion• Acknowledgements• Questions

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Blood Service in Finland

• Operationally and financially independent, not-for-profit organization within the Finnish Red Cross

• EU Blood Directive effective since 1 January 2005• Donation process, about 280 000 donations p.a.

• 61% of donated units from 17 permanent donation sites

• 39% of donated units by mobile units• Production process, about 440 000 components p.a.

• mainly leukocyte-depleted red cells and -platelets and fresh-frozen plasma

• production sites Helsinki, Tampere and Oulu• apheresis, only Helsinki, small volume

• Laboratories, about 2.5 million analyses p.a.• about 93% of tests blood group serological,

screening of infectious markers, quality control of components

• about 7% of tests various clinical tests for hospitals, maternity clinics and the open health care sector in general

• Clients, all public and private sector service providers• about 64% of sales to university hospitals in

Helsinki, Turku, Tampere, Kuopio and Oulu• www.bts.redcross.fi

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LIMS - since June 2007• The task to unify laboratory processes and serve on - line personnel/clients at various sites• Thin-client MS Internet Explorer 5.5+, three-tier architecture LabVantage Sapphire R4• Capasity for 50-75 simultaneous users and 2.5 M tests p.a., patient data from previous

systems converted into the database (about 20 M rows)• Interfaced with laboratory instruments, Progesa - system, Sonet - invoicing system, Turku

Univ. Hospital electronic patient record system (HL7) and the Helsinki Univ. Hospital, Dept.

of Cardiothoracic Surgery (integrated solution)

Process for Product Samples (QC)

Invoicingsystem

sampleinformation

sampleresults

Scheluder /LIMS add-on

sampleinformation

sampleresults

LIMS

Instruments

Process for Patient Samples

HospitalInformation System

LIMS

Requests/HL7

Results/HL7

Invoicingsystem

Instruments

sampleinformation

sampleresults

Invoices

clientinformation

activityinformation

Process for Donor Samples

Invoicingsystem

Donation/sampleinformation

Results

Sortingautomation

Progesa system

Arrived samples

sampleinformation

sampleresults

LIMS

Instruments

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Examples of Instrument Interfaces

Interface type Examples of instruments, and laboratory automation systems, interfaced

General on-line connection module of the LIMS system; suited for instruments compatible with ASTM 1394/1381 [1] protocols (or close to the protocols)

• AxSYM Immunoassay System (Abbott Diagnostics)

• Radiometer ABL 705 (Radiometer Copenhagen) • BacT/Alert3D® Microbial Detection System

(BioMérieux) • STA Compact Coagulation Analyzer (Roche

Diagnostics) • Olympus PK-7300 Fully Automated Microplate

System (Olympus) • BCS Coagulation System (Dade Behring) • Sysmex XT-2000i™ Automated Haematology

Analyzer (Sysmex) Text file transfer; e.g. laboratory automation systems

• Aurora (Sanguin) Serological Screening System controlling Elite automates (Bio Rad)

• Aurora Pooling (Sanguin), NAT pooling system controlling Tecan Genesis RSP 200 pipettors (Tecan) and Cobas Amplicor Amplification and Detection Automates (Roche Diagnostics)

Tailored interface • Olympus Sorting Drive program controlling Olympus OLA 2500 sorting automates

• Sysmex K1000 (Sysmex)

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Regulations: EU / Finland

• The European Directives concerning blood, tissues and organshttp://europa.eu.int/comm/health/horiz_legal.htm#32

• Finnish Law for Blood Service, 197/2005, effective as of 1 April 2005• Finnish Law for Medical Use of Human organs, tissue and cells,

101/2001• Finnish Personal Data Act, 523/1999• …• EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary

Use : Good Manufacturing Practice, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htmand Annex 11 Computerised systemshttp://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/anx11en.pdf

• Recommendations (policy statements to governments) adopted by the Council of Europe– Council of Europe: Guide to the Preparation, Use and Quality Assurance of

Blood Components Recommendation No. R (95) 15, 13th Ed. Strasbourg, France, Council of Europe Publishing 2007; 39-43, http://book.coe.int(European Guide)

§§

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Regulations: USA, Japan, Australia…

• USA: 21 CFR 211… Hardware, Software … and 21 CFR Part 11, aboutElectronic Records/Electronic Signatures, www.fda.gov/ora/compliance_ref/part11/; final guidancewww.fda.gov/cder/guidance/5667fnl.htm;

• Japan: www.meti.go.jp/english• Australia: Australian Code of GMP for Medicinal Products• …• WHO: WHO Guideline for GMP for Manufacture of Pharmaceutical

Products, http://whqlibdoc.who.int/trs/who_trs_908.pdf

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Guidelines

• PIC/S Secretariat, GMP Guide for Blood Establishments, PIC/S –Pharmaceutical Inspection Convention & Pharmaceutical Inspection co-operation Scheme, PE 005-2, 1 July 2004, p. 7 Computers, www.picscheme.org

• PIC/S Secretariat, Good Practices for Computerized Systems in Regulated ´GXP´Environments, PIC/S – Pharmaceutical InspectionConvention & Pharmaceutical Inspection co-operation Scheme, PI-011-2, 1 July 2004, www.picscheme.org (PIC/S Guidance)

• ISPE, GAMP Guide for Validation of Automated Systems, GAMP 4 GoodAutomated Manufacturing Practise, International Society of Pharmaceutical Engineering, see www.ispe.org

• ISBT, International Society of Blood Transfusion, Guidelines for validationand maintaining the validation state of automated systems in bloodbanking, Vox Sang 2003; 85: S1-S14, see www.isbt-web.org/documentation

• ISBT, International Society of Blood Transfusion, ISBT Guidelines for information security in transfusion medicine, Vox Sang 2006; 91: S1-S23, see www.isbt-web.org/documentation

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Good Automated Manufacturing Practise(GAMP)

• A technical sub-committee of ISPE• To promote the understanding of the regulation• To promote the use of automated systems within healthcare industries• Five GAMP regions

• GAMP Europe• GAMP Americas• GAMP Japan • GAMP Brazil • GAMP PR (Puerto Rico)

www.ispe.org

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… apply to the Interfaces

• European Guide, Chapter 4: Data processing systems pp. 39-43 "…critical to product and quality…systems must be fully validated to ensure that they meetpredetermined specifications for their functions, they correctly preserve data integrity, and that their use is properly integrated into the centre's operatingprocedures…" (Para 1) and …"The system components are presented with alltypes of expected interaction including normal value, boundary, invalid and special case inputs… In the actual operating environment, functional tests areperformed to demonstrate that: proper information passes correctly throughsystem interfaces, including appropriate data transfer to other lab systems, ifapplicable (Para 3.1 and 3.2.c)

• PIC/S Guidance, Chapter 6: The structure and functions of the computersystem(s) p. 7 "A computerized system is composed of the computer systemand the controlled function or process. The computer sýstem is composed of all computer hardware, firmware, installed devices, and the software controlling the operation of the computer… Interfaces and networkedfunctions through LAN and WAN are aspects of the computerized system and operating environment potentially linking a multitude of computers and applications. A firms's GxP system environment, functionality and interactionswith other system(s) needs to be clearly defined and controlled in respect of GMP Annex 11… and Chapter 21, Electronic records and electronic signatures, p. 29 …"provision for external access" ('open' systems)…

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Data Interchange Challenges

• Between information management system and– instruments (instrument interfaces)– other internal- and external systems (system interfaces)

• Lack of a common and open definition for the instrumentinterface

• Lack of a common conceptual data interchange frameworkbetween instruments and information systems

• => Since no universal solutions exist, all data interfacesneed application-specific consideration and have to beprogrammed

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Technical and Conceptual Challenges

• Compatibility of instrument operating system withthe IT infrastructure to facilitate the connection to the Blood Service network

• Technical compliance level with the ASTM high-and low level protocols

• A variable level of technical manuals and supportavailable

• Availability of one- and bidirectionalcommunication

• Selection between batch- or query mode• Selection of relevant data to be transferred• Human checkpoint of results• Alternative system in case of a breakdown• Information security (closed vs. open system)• Risk assessment - interfaces are critical elements

within a GMP critical system – validation!

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Communication Related Challenges

• Co-operation and information exchange between the partiesinvolved: Blood Service, the instrument (automation system) supplier, the LIMS supplier, the IT service provider(s), the external client and their IT service provider(s)

• A BS expert and the IT expert do not necessarily speak the samelanguage. Yet a common understanding of the functionalitiesneeded is required

• How to understand the variable technical solutions suggestedand the consequences of the choices made?

• Functional specification, design specification, testing of the pilotversions, correction of errors and possible modification of the specifications, retesting… an iterative process until the interfaceoperates as specified

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As a consequence

• The interfacing takes time and extra effort• The amount of programming and the amount of testing

needed varies depending on – Instrument (automation system) interface type– Availability of detailed technical information– Availability of support from the instrument or system supplier– Number of parties involved– Complexity of the user requirements set for a particular

interface– …– Special Experts available for the job

=> Extra costs!

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Standardization and Data Interchange Successes

• "…global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare." Clinical Data Interchange … www.cdisc.org

• HL7 "Level Seven" refers to the highest level of the International Organization for Standardization (ISO) communications model for Open Systems Interconnection (OSI) - the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. The seventh level supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations and, most importantly, data exchange structuring. The HL7 Version 2 Messaging Standard — Application Protocol for Electronic Data Exchange in HealthcareEnvironments — is considered to be the workhorse of data exchange in healthcare and is the most widely implemented standard for healthcare information in the world." www.hl7.org

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Standardization and the Data Interchangein Transfusion Medicine Activities

• "Standard Specification for Transferring InformationBetween Blood Bank Equipment and InformationManagement Systems" ICCBBA draft standard from 1998 www.iccbba.org on the basis of ASTM E 1394/1381…

• ASTM E 1394/1381 withdrawn in year 2002 and replacedby ANSI/NCCLS standards, such as Laboratory Automation: Communication with Automated Clinical LaboratorySystems, Instruments, Devices, and Information Systems; Approved Standard; NCCLS Document AUTO3-A, ISBN 1-56238-428-7 www.clsi.org

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Task Force on Automated SystemInterface

• Established in 2006 to develop a standard specification for transferring information between equipment and informationmanagement systems within transfusion medicine activities

• Timeframe: the standard suggestion should be presented for consideration by ISBT in 2009/10

• Ongoing activities– Building networks: Apheresis (K. Bierbaum), Production (P. Potstra),

Testing Instruments (NN) – Compiling a list of instruments and equipment (B. Lupo)– Comparison of the ANSI/NCCLS standard AUTO3-A with the draft

ICCBBA standard from 1998 … and reviewing of data interchange standards such as ASTM E 1238, 1381, 1394, 1467, 1578, 1639; ANSI X3.4, ISO 8859-1, ISO/IEC 10646, 7064; plus CLSI, HL7, CEN TC 250, ISO TC215, IEEE 1073 protocols 18

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• Participants - a balanced mix between blood services and - banks and the industries– Transfusion medicine software suppliers: MAK-SYSTEM, Inlog,

Databyrån, WyndGate, LabCraft, ... – Laboratory Information Management System/Laboratory Information

System (LIMS/LIS) suppliers: …– Laboratory instrument and automation systems suppliers: Abbott, Ortho,

Olympus, Diamed, Roche, Gen-probe, ...– Apheresis systems: Baxter, Gambro, Heamonetics, ...– Blood component separators: Baxter, Terumo, Fresenius, … – Centrifuges: Kendro, Hettich, Beckman, ... – Bacterial testing systems: BioMeriuex BacT/Alert System, Pall Biomedical

BDS System

• Contact– chair person Pia Bruce, M.Sc., MBA– Finnish Red Cross Blood Service– e-mail: pia.bruce@bts.redcross.fi

Task Force on Automated SystemInterface, Cont.

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Conclusion

• Risk assessment – interfaces are critical within a GMP critical system (product quality, patient safety and information security)

• Regulations apply – validation!• Challenges and extra costs arise due to a lack of a common

and open definition for the instrument interface, and a lackof a common conceptual framework for data interchange

• Standardization is a need recognized by the end users and suppliers within the transfusion medicine activities

• ISBT launced a new Automated System Interface TaskForce in 2006 to establish a standard specification

• The timeframe required will be about three years (ISBT 2009/10)

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Acknowledgements

• Charles Munk, Chairman of the ISBT WPIT until 6/2007• Lasse Koskinen, Oy Fision ltd• Karo Kuokkanen, Juha Hinkula and Lari Alopaeus,

Whitelake Software Point Oy• Akif Ali, Marjatta Hirvonen, Ulf Lillsunde, Enni Lindeberg,

Ari Nieminen, Ritva Toivanen, and Marja Sihvola, and the LIMS Project Team, FRC Blood Service

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Questions?

…and Thank You!

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Interfacing your Automated Instrument

Terry Downs MT(ASCP)SBBSupervisor, Blood BankUniversity of Michigan Health Systemtdowns@umich.edu

What is an Interface?

Automatic, electronic connection between an analyzer and a computer for exchanging information2 or more software applications are linked together and communicate as oneDifferent protocols available

Flow of data

Serves as means of communication between the lab system and instrumentInterface translates tests and accession numbers into a language the instrument can understand (downloading)Test results translated into a language the LIS can understand (uploading)

Unidirectional Interface

Samples Results Reports

Instrument performs test and sends results to interface/LIS

LIS

Bidirectional Interface

SamplesResults

ReportsTest Requests

Host downloads specimen ID test order informationInstrument uploads specimen ID and test result information

Allows different array of testing, i.e. TS, BT, DAT or AS

LIS

Query Bidirectional Interface

Samples

Results

ReportsTest Requests

Test Query

Instrument loaded with bar code labeled samplesQuery to host is generated for download of test requested

Host looks up in database and generates download of test order

LIS

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Distributed ProcessingQuery Conversion

Samples

Results

Reports

Test Requests

Test Query

Host system dowloads to interface deviceStore orders in buffer memory

Instrument(s) queries the interface device LIS

Test RequestsResults

Interface Device

Interface Requirements

I/O port on instrument and host system with connection cableHardware

PC connected to automated instrument for data managementLIS system with hardware platform

Software on instrument and LIS

Interface Variables

LIS and automated instrumentsInstruments have evolvedLIS’s have evolvedIn Blood Banking, instrument is newer while LIS may be older Old software on LIS and old but different data interchange standard

Primary Problems

Lack of standardization of data formats and communication protocolsChaotic communication environment has resulted in substantial rewriting of interface softwareLeads to increased costs and end-user development and validation times

Interface Specifications

Definition of the physical connection, i.e. cableSpecifications of communication protocolsDescription of the data format produced including flag conditions and definitions

Interface Architecture

Straight in, software onlyBlack boxPC-based software interfacesIntelligent intermediate devices, AKA middleware

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Inside the Interface

Mid 1980’s International Organization for Standardization (ISO) proposed a model for coordination of standards developmentModel envisions a layered architecture for interfaces7 functional layers each with their own responsibilities with regards to interface

1Physical1

2Data-link2

3Network3

4Transport4

5Session5

6Presentation6

7Application7

InstrumentLayerLIS

ISO Seven Layer Reference Model

Physical

Used to develop and market the compatible equipment necessary for connectionModemsCablesMajority of interface problems related to cabling

Data-link

Moves the informationData presented in ASCII character formSimplifies interface development as formatted results easily printed or viewedError and flow control here

Network

If LIS is receiving data from more than one instrumentInsures identification of data source

Transport

Flow of character data in both directionsBaud rate or rate that characters can moveCapability to control data flow and error checking-retransmission if necessary“Handshake” between instrument and LIS to regulate flow of data

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Session

Provides the structure for communicating between applicationsEstablishes, manages and terminates the connection created between sessions

Presentation

Information being passed must be represented in a format that is understood by both devicesWith ASCII, messages viewed with a text editorEach line of data broken into fields separated by a field separator

Application

Data is moved and information managed!

Interface Communication Standards

Electrical specsConnectors and cablesCommunication parametersCommunication protocolsMessage blockingMessage structureMessage content

ASTM Standard

American Society for Testing and MaterialsGoal is to simplify the connection of instruments and information systemsPlug-and-play??Reality

Partial implementation of standardsVery complicatedBroad specsSomewhat outdated depending on who you talk to

Common Data Format

Convert instrument data into a Common Data Format and Communication ProtocolData is now flexible at the interface level for modification for LIS system

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HL-7 Format

Health Level 7Originally defined for communications between LIS and HISGaining acceptance for use between instruments and LIS

ASTM Output from instrument[10/5/07 10:02:08 AM]-> Send:

P|1|(0000)2222-222-2|||||19430629|F|[10/5/07 10:02:08 AM]-> Send:

O|1|27800210C|7451-7|^^^Type_2CellScreen.gru^ABD 2 Cell Screen.pln|R|20071005092416|||||||||||||||||||WADIANA^1272^3|F|

[10/5/07 10:02:08 AM]-> Send: R|1|^^^Type_2CellScreen.gru^ABD 2 Cell Screen.pln|-^-^4+^-^4+^3+^O^Pos^-^-^Neg|A^B^D^Ctl^A1Cell^BCell^Group^Rh^Cell 1^Cell 2^AbScr||N||F||bbmmh|

Capture File Translated to HL7MSH|^~|&|ResultNet||||2007105100954||ORU|

141670|P2.3PID|1||(00002140-389-1||||19430629|FORC||||||||||bbmmhOBR|1||27800210C||||||||||||||||7452^1OBX|1||A||0|||NormalNTE|1||ABD Reverse.plnOBX|2||B||0|||NormalNTE|1||ABD Reverse.pln

Etc.....

Reasons to Interface

Safer FasterFuture stateAutoverification

Planning for Interfaces

Trend is for bi-directional interfaces particularly random access testingCost to develop interfaceOperation of interfacesIntegration with other LIS functionsPhysical layout-cable length, hardwareVendor support

Planning for Interfaces

What cables are needed?What sockets are on instrument and LIS for connection?What is the format of data from instrument?Can the LIS receive it in that format?Are there symbols the instrument uses that LIS cannot use?Is middleware needed to translate?

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Learning Curve

LIS languageAutomated instrument languageConnection languageMiddleware language, if needed

Common ProblemsInadequate instrument specificationsFinger pointing between vendor and LISUpdated instrument may change interfaceFamiliarity with operation and configurationSufficient time to implementInterfacing a new instrument into an old LISNew workflow integrated with old workflow can present problemsAccession label compatibility

Just Remember

When it is all over,no one wants to go back!

References

Information Technology in Transfusion Medicine, edited by S. Butch and M. SimpsonInterfacing the Clinical Laboratory: A Primer for LIS Managers, J Selmyer and B. Cloutierwww.hl7.orgwww.astm.org

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“Issues in Selecting Automation for the Transfusion Service”

AABB Annual Meeting, Anaheim, CA

October 22, 2007

Nancy M. Nikolis, BS, BB(ASCP)Supervisor/Systems CoordinatorMaimonides Medical Center

Blood Bank Team

Alicia Gomensoro, MD, Blood Bank Director

Nancy M. Nikolis, Blood Bank Supervisor & Systems Coordinator

George Theodorakis, Blood Bank Supervisor

Shailesh Macwan, Donor Center Supervisor & QA Officer

Wai Moy, Assistant Supervisor

Natalie Palumbo, Administrative Assistant

The Blood Bank/Donor Center Team

21 - Full Time Employees in the Blood Bank5.5 – Full Time Employees in the Blood Donor Center

Statistics:

• 705 Bed Hospital

• 34,000 Type and Screens

• 25,000 Crossmatches

• 15,000 Red Cell Transfusions

• 8,000 Fresh Frozen Plasma Transfusions

• 6,000 Platelet Transfusions

• 1,000 Cryoprecipitate Transfusions

• 6,500 Whole Blood Collections

• 600 Trima Apheresis Collections

• Transmissible Disease Testing for donors and patients

Problems that we faced:

► Staffing► Clerical Errors► Technical Errors► Standardization of procedures

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Our solution was…automation AABB Standard 3.1

• AABB Standards, 24th Edition states“The blood bank or transfusion service shall have a process to define the selection criteria for equipment.”

Our problem was…how to pick the best instrument for our laboratory So, we sat down and brainstormed… What

do we want in an instrument???

Qualities we sought in an automated blood type and screen analyzer:

• Ease of use

• Reagent quality control can be recorded and is required at 24 hour interval

• Turnaround time for results is within an hour

• STAT capability

• Large batch size capability

Qualities we sought in an automated blood type and screen analyzer (continued…)

• Patient testing (2-3 cell antibody screen) and donor testing (pool antibody screen) can be accomplished

• Each step of patient and donor testing is captured, together with date, time and electronic signature of staff performing testing/task.

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•Reports can be generated that assist in statistical analysis of tests performed, (i.e.: # of tests done per year, # of NTD’s (no type determined), # of positive antibody screens, # of aborted runs, etc)

•Archiving of data is accurate, simple and quick.

•The system is ISBT-capable.

•Instrument interfaces exist for HCLL computer system.

•Security is guaranteed with user access and password codes.

•Users may be granted different levels of access.

•Aborted runs are printed for ease in review and tracking

•Backup system exists in the event of system downtime.

•Downtime is at a minimum and technical service visits are within 24 hours of phone call.

We devised a series of questions to help us with our decision. For example:

Which other sites are using the equipment?

Could we schedule a visit to a current site with a similar workload?

How many technical support specialists does the company have available in the region?

Do they offer 24/7 telephone support and field support?

Is there a national users group and how often do they meet?

What costs are included in the purchase/reagent rental? For example:

Maintenance costsInterfacesUninterrupted Power Supply (UPS)QC related supplemental equipment

-scale-standard weights

Decontamination supplies

What are the specimen requirements?

What is the turnaround time?

What are the space requirements?

Are there special plumbing requirements, i.e.: water supply, DI water, waste receptacles.

What are the electrical requirements?

What is the largest batch size that can be run?

Are the turnaround times different depending on batch size?

What is the NTD rate (no type determined)?

What is your rate for false positive antibody screens?

What reports are available?

Describe how stats are processed. Is there a stat interrupt?

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What disposables are required and reagents are required?

What is their expiration date once opened?

How are plates run-i.e.: strips or full plates?

What is your policy for aborted or failed runs?

What is the downtime associated with daily QC, backups and maintenance?

Will maintenance requirements be kept track of by the instrument?

Daily, weekly, monthly, annually?

What are some examples of common troubleshooting problems?

How easily are the mechanical parts accessed?

Are there any space requirements for access to the instrument?

What computer interfaces are available? Are they bidirectional? Are they HL7?

How are results verified before accepted into computer system?

Does your system have anti-virus software?

What kind of training is provided by your company? How many staff is trained?

What is included if training is off-site (ie: hotel, transportation)?

How are software upgrades done? What is the downtime, if any?

Does your company need remote access to the instrument?

Have any parts been upgraded for the instrument?

Describe the levels of security for the instrument.

Will vendor’s technical support be on-site for go-live?

Depending on how many instruments you evaluate, create a spreadsheet and for each item assign a point system.

An unfavorable response is given a “0”.A response you can live with is given a “1”The most favorable response is given a “2”For example:

253Total Score:121

What is the NTD rate (no type determined)

021What is the turnaround time?111What is the overall cost?

Instrument C

Instrument B

Instrument AQuestion

Our choice was…..

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Once your entire evaluation is done, present it to your administration and say a prayer ….

Soon enough you’ll have your new instrument in place and ready for the next frontier of implementation……..

V A L I D A T I O N

I can be reached at:Nancy M. Nikolis, BS, BB (ASCP)Office: 718-283-7524Email: nnikolis@maimonidesmed.org

GOOD LUCK!!

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Validation and Correlation of Blood Bank Analyzers

Presented by:Leana Serrano-Rahman MPH,

(MT)ASCP, (CQA) ASQMontefiore Medical Center

Bronx, NY

Montefiore Medical CenterTwo campuses -1,122 bedsOne Donor SuitePerforms approximately 9K TS/monthlyTransfuses approximately 25,000 red cellsTwo analyzers at each campusBoth campuses perform PEG tube testing

Validation? Correlation?

Let’s start with the simple definition…

Validation

Documented evidence that a specific process will consistently produce a specified productThe product meets the predetermined specifications and quality attributesDocument that the outcome of the process occurs “as expected”

Validation

Blood Bank software validation uses the same methodologies utilized for the validation of a Blood Bank analyzer

Correlation of Blood Bank Analyzers

NYS QA Std 15 states that a lab that performs the same test by different methods or instruments, or performs the same test at multiple sites shall have a system in place that evaluates and defines the relationship between test results at least 2 times a year.

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Validation ? Correlation?Where do I go from here?I want a quality product AND I also want to….

Validation ? Correlation?…satisfy the regulatory agencies!

One of my favorite expressions…

During any type of validation, one of my favorite expressions is…”Just, kill me, kill me now!”

Validation Guidelines

Develop a validation plan/protocolIdentify the key players (who signs off on plan, summary, etc.)Execute validation planAnalysis of data collectedWrite a validation summary

Validation Plan/Protocol

Purpose- ”Produce documented evidence with a high level of assurance that all parts related to the use of an automated system work correctly and consistently.”Responsible Individuals for Execution- QA Manager, Lead Tech etcSign off of plan? Blood Bank DirectorSign off into production?

Validation Plan/Protocol

Description of analyzerActivities to be conducted for validationProcedures on “how” validation is going to be conductedInstallation Qualification (vendor)-system is installed correctly

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Validation Plan/ProtocolOperational Qualification (OQ) operating parameters are working appropriatelyPerformance Qualification (PQ) consistency of the computerized processTrainingTestingDiscrepancy Resolution

Ready to execute plan…

Relax…you’re almost there…

Execution of Validation

Super users were sent for trainingIQ, PQ, OQ were performed by the vendor. The vendor has a checklist that was reviewed by the Blood Bank ManagerPQ Vendor vs. End User?

Execution of Validation- I

Run known blood types and neg antibody screen. Cover all types.Run a grossly hemolyzed specimenRun a QNS specimenDepending on the error codes of your analyzer, run specimens that would error out. Cover the whole spectrum.

Save the print outs!!

Execution of Validation- II

Instrument Parallel TestingThis was used as a form of performance validationPerformed patient testing (TS) using both the analyzer and the current reference method.Sample Size 200 patient specimens

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Execution of Validation- III

ABIDSmall sample sizeRule outs with double dose cells performed by PEG tubeCompared historical cases as well as active patient specimens

Execution of Validation- IV

Known antisera-ABIDSerial dilution of known antiseraTested PEG tube vs analyzerUsed Anti Fya, Anti Jka and anti S

Execution of Validation- VInterface ValidationVerified instrument output posted correctly in patient recordVerify any applicable interface reports

Validation Summary

Summarize findingsInterpretation of results Any resolutions/corrective action of unexpected resultsProduction releaseSign off by appropriate authority

Reminders…Record retentionInstrument will still need future validation when applicableFile training recordsStore all print outsOperational SOP before go liveProficiency test

If I could do it over…

Would have run more specimens-at least 500.Tested more invalids, QNS specimens etc.Justify difference in run sizeSpecificity? Sensitivity?

5

Sensitivity/Specificity

Sensitivity “how often a test is positive when it is expected to be”Specificity “how often a test is negative when it is expected to be”Criteria set by facility

Sensitivity

Specificity Specificity continued…

Correlation of AnalyzersMultiple sitesSplit specimensProficiency TestSame specimen Performed twice a yearAssures that there are no discrepancy in results between sites or analyzers

Montefiore’s ExperienceNo method is perfectOur analyzers have met our needs-close to 90% of our TS are performed on the analyzersOur validation plans did not include specificity/sensitivity calculations and we have had no significant post live issues

6

What’s harder than validation??

Raising two kids…this is NOT an exact science…

References

Guidelines on General Process Validation. Center for Drug and Biologics; Center for Devices and Radiological Health; FDA. May 1987.ISBT-Guidelines for validation and maintaining the validation state of automated systems in Blood Bank. Vox Sang (2003) 85(Suppl.1), S1-S14

ReferencesGeneral Principles of Software Validation; Final Guidance for Industry and FDA Staff. Center for Drug and Biologics; Center for Devices and Radiological Health; FDA. 1/11/02Galileo Validation Guidelines. Immucor2005

Special Thanks

Montefiore Medical Center Blood Bank StaffDr Joan Uehlinger Blood Bank DirectorDr Ljiljana Vasovic Assoc Blood Bank DirectorDr Kala Mohandas Assoc Blood Bank Director